# NIDDK Follow-up on Subjects and Immunological Assessments in The Environmental Determinants of Diabetes In The Young Study (TEDDY) (UC4)

> **NIH NIH UC4** · UNIVERSITY OF SOUTH FLORIDA · 2020 · $1,000,000

## Abstract

Abstract
The University of South Florida is uniquely qualified to conduct the activities specified in this limited competition
RFA. The specific aims of this application are to describe plans to coordinate the recruitment of immune
markers collaborator(s) and to continue the DCC's functions in support of TEDDY subject follow-up.
The competition will be sufficient to attract applications from collaborators with the capability to perform
reliable measurements, and to make the data available to TEDDY investigators for collaborative,
integrative analyses. In addition, this application is intended to support the TEDDY DCC for subject follow-up
in the final two years of the award. The proposed Data Coordinating Center activities in years 4 and 5 include:
1) Executing the study protocol for follow-up of TEDDY study participants according to schedules and
procedures contained in the study's Manual of Operations and in collaboration with the Clinical Centers at
which participants are enrolled and with NIDDK staff. 2) Receiving, managing, and analyzing data obtained
from the clinical centers 3). Monitoring of adherence to the research plan by conducting site visits to monitor
the quality of record keeping, source documentation and the accuracy of data entry and also for overseeing
data quality control. Steering Committee, subcommittee, and external evaluation committee meetings and
workshops.4). Providing statistical support, expertise and oversight throughout the study. 5) Providing study-
wide communications, dissemination of study materials such as protocols, Manual of Operations, forms or
other study documents, and development and maintenance of the web site. 6) Playing a key role in the
operational conduct of TEDDY, providing training and technical assistance to the Clinical Centers in
performance of the follow-up assessments; assisting in protocol implementation; and working in conjunction
with the Clinical Centers and NIDDK staff to oversee all aspects of Clinical Center performance, including
timeliness and quality of data and biosample submission. 7) Procurement and administration of subcontracts
for laboratory services, including: central human leukocyte antigen laboratory; the autoantibody laboratories,
the mRNA laboratories, infectious disease laboratories, and other laboratories as needed. 8) Providing
administrative and logistical support services for the TEDDY Study Group including preparation of publications,
and organizing periodic meetings for the study group and subcommittees, workshops, and conference calls. 9)
Transfer of all biosamples and data to the NIDDK central repositories according to a timeline developed with
the NIDDK. and 10) Working closely with the Clinical Centers in a collaborative and interactive manner and
serving on the Steering Committee.

## Key facts

- **NIH application ID:** 10088137
- **Project number:** 3UC4DK117483-01S3
- **Recipient organization:** UNIVERSITY OF SOUTH FLORIDA
- **Principal Investigator:** JEFFREY P KRISCHER
- **Activity code:** UC4 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,000,000
- **Award type:** 3
- **Project period:** 2017-09-15 → 2022-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10088137

## Citation

> US National Institutes of Health, RePORTER application 10088137, NIDDK Follow-up on Subjects and Immunological Assessments in The Environmental Determinants of Diabetes In The Young Study (TEDDY) (UC4) (3UC4DK117483-01S3). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10088137. Licensed CC0.

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